International Pharmacovigilance (PV) Senior Manager - APAC
Vertex · AU
Job Description General Summary: The International Pharmacovigilance (PV) Senior Manager - APAC is a member of the Global Patient Safety (GPS) International...
Job description
Job Description General Summary: The International Pharmacovigilance (PV) Senior Manager - APAC is a member of the Global Patient Safety (GPS) International Pharmacovigilance Team with sufficient authority to implement changes to Vertex’s PV Systems to promote, keep, and improve compliance with local regulatory requirements throughout APAC with an emphasis on China. The International PV Senior Manager role works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures, and to confirm compliance with applicable regulatory requirements. This individual ensures that all work performed is in accordance with relevant regulatory guidelines. REQUIRED SKILLS: - Excellent written and oral communication skills in English and Chinese - China PV experience - Strong understanding of China GVP and local PV execution practice - Experience working with local PV representatives, affiliates, or service providers in China KEY RESPONSIBILITIES: - Ensures that all PV activities and GPS procedures are compliant with global and local PV regulations - Ensures required GPS contractual agreements are developed and finalized timely to...